Kornimate/medical-research-clean huggingface dataset:
the effect of neuro-orthosis on gait performer in post stroke subjects

Conditions: Stroke

Summary: the aim of this study is to verify the effectiveness of foot drop stimulation (fds) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.

the stroke subjects are going to perform the walking training with foot drop stimulator on the treadmill. all the evaluations will be performed with a foot drop stimulator turned off and on. one month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of fds.

Eligibility criteria:
inclusion criteria: * subjects with ischemic or hemorrhagic stroke diagnosis. * mild, moderate or severe hemiparesis (chronic stroke - at least 6 months) * minimal cognitive ability to understand commands * able to walk 10 meters unassisted or with minimal assistance exclusion criteria: * secondary musculoskeletal disorder involving the lower limb * contraindication for electrical stimulation

Keywords: cerebrovascular stroke cerebral stroke cerebrovascular accident neurorehabilitation gait rehabilitation
peripheral blood biomarkers associated with cipn

Conditions: Peripheral Neuropathy, Secondary to Drugs or Chemicals

Summary: the investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.

the investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. the investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. the investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.

Eligibility criteria:
inclusion criteria: * diagnosis of a tumor for which platinums, vinca alkaloids, bortezomib or taxanes are indicated * no prior history of diabetic, anatomical or regional neuropathies (except pre-existing cipn) * age ≥ 18 years * capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. exclusion criteria: * inability to give consent * inability to tolerate venipuncture for any reason * age \< 18 years * any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the pi or caring physician * consent refusal by patient

Keywords: cipn
relationship between serum n/ofq and type 2 diabetic nephropathy

Conditions: Diabetic Nephropathy Type 2

Summary: at present, the early diagnosis ability of diabetic nephropathy (dkd) is relatively poor, leading to some missed diagnosis of early disease patients. at the same time, because dkd patients have complex metabolic disorders, once they develop to end-stage renal disease, compared with other renal diseases, the treatment of dkd is more difficult and the prognosis is poor. at present, the main treatment for dkd is to strengthen blood glucose control and control blood pressure through renin angiotensin aldosterone system (raas) to delay the occurrence and development of dkd, but it can not reduce the risk of most patients progressing to end-stage renal disease (esrd). in recent years, it is becoming a new therapeutic target for dkd to control the inflammatory response by targeting the inflammatory factors and inflammatory signaling pathways. therefore, this study attempts to explore the correlation between n / ofq and the occurrence and development of type 2 dkd, and seek new theoretical basis for the potential treatment of inflammation.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients are in line with the relevant diagnostic criteria in china's guideline for prevention and treatment of type 2 diabetes (2017 edition). * patients with diabetic nephropathy are in line with the relevant diagnostic criteria in the expert consensus on diabetic nephropathy (2014 edition). exclusion criteria: * primary kidney disease (e.g. acute and chronic glomerulonephritis, immune and hereditary nephropathy, pyelonephritis, gout related nephropathy, etc.) * abnormal changes of microalbuminuria and urine glucose caused by other factors (such as urinary system infection, fever, 24-hour strenuous exercise, intractable hypertension, congestive heart failure, pregnancy, ketoacidosis, etc.) * failure of other important organs (heart, lung and liver) in the whole body; * activity of urinary sediment; * the glomerular filtration rate decreased by more than 30% within 2-3 months after treatment with angiotensin converting enzyme inhibitor (acei) or angiotensin ⅱ receptor antagonist (arb); * patients with cancer, trauma, stress and other endocrine diseases; * patients with type 1 diabetes and kidney injury; * congenital mental retardation or poor compliance; * the informed consent was not signed.
response to booster doses of hepatitis b vaccine in children and adolescents

Conditions: Hepatitis

Summary: the purpose of this study is to determine the immune response to an additional (booster) dose of hepatitis b vaccine 5-14 years after a three dose series was given

routine hepatitis b vaccination beginning at birth was provided to alaska natives several years before other areas of the united states began routine infant hepatitis b vaccination programs. follow up studies of hepatitis b immunity among alaska native children provide an early opportunity to assess long term protection against hepatitis b virus (hbv) infection for children vaccinated at birth with the currently used recombinant vaccine. this protocol describes an evaluation of long-term protection against hbv infection among children who received the recombinant hepatitis b vaccine beginning at birth, and who currently receive medical care at the alaska native medical center (anmc) in anchorage, alaska. the specific objective of this study is to evaluate the immune response to a five microgram dose of recombinant hepatitis b vaccine among 5-6 year old and 10-14 year old children who received the primary recombinant hepatitis b vaccine series beginning at birth. the concentration of antibodies to hepatitis b surface antigen (anti-hbs) will be measured immediately before administering the vaccine, and compared with levels in serum drawn 1, 2 and 4 weeks afterwards. a rapid antibody response (anamnestic response) indicates that immune memory, and therefore immunity to hbv infection, is preserved. the frequency and magnitude of the anamnestic response for the group of older children will be compared to that of the younger group. currently, there is no recommendation for a routine booster dose of vaccine after receiving three doses at birth. this study will provide valuable information regarding the need for and response to an additional dose (booster dose) of hepatitis b vaccine among children entering primary school or adolescence. if evidence of waning immune memory (as measured by a delayed or diminished response to the additional dose of vaccine) is found, these two age groups would be the most easily accessible for routine delivery of a booster dose.

Eligibility criteria:
inclusion criteria: received 3 doses of hepatitis b vaccine during infancy, beginning at birth exclusion criteria: mother hbsag-positive immunosuppressed

Keywords: vaccine hepatitis
study of tislelizumab, pamiparib, and other investigational agents in participants with advanced malignancies

Conditions: Advanced Malignancies

Summary: this is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of beigene investigational drugs in participants with advanced malignancies who participated in a prior beigene-sponsored clinical study (parent study).

for the purposes of this study, "study treatment" will refer to all investigational agents. a parent study is defined as the original beigene-sponsored clinical trial in which the participant was initially enrolled and received beigene investigational drugs (with or without other treatments).

Eligibility criteria:
key inclusion criteria: 1. currently participating in a beigene-sponsored eligible parent study 2. fulfills treatment criteria specified in the parent study protocol 3. in the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study treatments. 4. the first dose of study treatment in the lte study will be received within the treatment interruption period allowed by the parent study: 1. "treatment interruption" (unplanned pause in study treatment) and "treatment break" (planned stop of study therapy) are not interchangeable. restarting study treatment beyond the interruption period allowed by the parent study or after a treatment break will be determined by the investigator and the sponsor. participants who have not restarted treatment within 1 year of starting a treatment break must discontinue treatment. specific inclusion criteria for participants who continue survival follow-up only in the extension study: 1. currently participating in a beigene-sponsored eligible parent study in the survival follow-up portion 2. parent study plans to have survival analysis key exclusion criteria: 1. permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent 2. have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study 3. have a life-threatening illness, medical condition, or organ system dysfunction that in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of investigational drugs, or put the study outcomes at undue risk 4. underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the lte study 5. pregnant or lactating women note: other protocol defined inclusion/exclusion criteria may apply.
feasibility study: evaluation of the ulthera® system for treatment of abdominal tissue

Conditions: Skin Laxity; Skin Crepiness

Summary: enrolled subjects will receive one ultherapytm treatment on the abdomen. follow-up visits will occur at 90 and 180 days post-treatment. study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

this is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the ulthera® system for improving laxity/crepiness and texture of abdominal tissue. changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. global aesthetic improvement scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Eligibility criteria:
inclusion criteria: * male or female, aged 25 to 60 years. * subject in good health. * skin laxity in the abdomen * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat in the abdomen. * excessive skin laxity on the abdomen. * significant scarring in areas to be treated. * open wounds or lesions in the area to be treated. * inability to understand the protocol or to give informed consent. * bmi equal to and greater than 30.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
cognitive impairment in colorectal cancer patients receiving cytotoxic chemotherapy

Conditions: Neoplasm, Colorectal; Cognitive Impairment; Cognitive Dysfunction; Cognitive Change; Chemo-brain; Chemo Fog; Chemotherapy Effect; Cognitive Decline

Summary: the purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at parkview cancer institute. this information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.


Eligibility criteria:
inclusion criteria: * signed written informed consent must be obtained and documented according to international conference on harmonisation (ich)- good clinical practice (gcp), the local regulatory requirements, and permission to use private health information in accordance with the health insurance portability and accountability act (hipaa) prior to study-specific screening procedures. must be able to provide study-specific informed consent prior to study entry. * a histologically-confirmed colorectal tumor * patients who will be treated with cytotoxic chemotherapies including capecitabine, oxaliplatin, 5 fluorouracil, and irinotecan are eligible. * patients must not have received cytotoxic chemotherapy previous to enrollment. exclusion criteria: * prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents * patients having mental incompetence as assessed by study pi, which would hinder completion of the surveys * pregnant or breastfeeding * any known brain metastases * non-english speaking patients * patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, alzheimer's disease, parkinson's disease, huntington's disease, and creutzfeldt-jakob disease. * patients deemed inappropriate to participate in this study by the study pi or coordinator will be excluded.

Keywords: palliative care palliative oncology supportive care supportive oncology cognitive impairment chemo brain
cetrorelix pamoate im regimens in patients with symptomatic benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hypertrophy

Summary: benign prostatic hyperplasia (bph) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. the purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate. for this study, study medication (cetrorelix pamoate) is administered by injection in the buttocks (intramuscular).


Eligibility criteria:
inclusion criteria: * benign prostatic hyperplasia, based on medical history * voiding symptoms * uroflow (max) 5-15ml/sec exclusion criteria: * urgent need for prostate surgery * history of allergic reaction to peptide * major organ dysfunction * prior surgical treatment of the prostate or bladder * current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (botox) within the last 6 months prior to trial medication at week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at week 0 * urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy * history of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months

Keywords: cetrorelix bph
a study of ixekizumab (ly2439821) in participants with moderate-to-severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Eligibility criteria:
inclusion criteria: * chronic plaque psoriasis for at least 6 months before baseline * failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy) * psoriasis area severity index (pasi) score at least 10 at screening and at baseline * participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment exclusion criteria: * predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis * history of drug-induced psoriasis * cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study * have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline * concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline * have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol * have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (il)-17 or il-12/23 antagonists, or have received treatment with other il-17 or il-12/23 antagonists * have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study * have had a vaccination with bacillus calmette-guérin (bcg) within 12 months of baseline or intend to have vaccination with bcg during the course of the study or within 12 months of completing treatment in this study * have a known allergy or hypersensitivity to latex * have had any major surgery within 8 weeks of baseline or will require such during the study * have active or history of malignant disease within 5 years prior to baseline * significant uncontrolled disorder * ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline * are women who are lactating or breast-feeding
safety and feasibility of tachosil®: application on esophageal anastomoses

Conditions: Esophageal Disease; Gastric Disease

Summary: rationale: the construction of esophageal anastomoses is associated with considerable risk at postoperative anastomotic leakage. application of tachosil®, a tissue sealant with human fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially prevent anastomotic leakage. objective: evaluation of feasibility and safety of tachosil® application on esophageal anastomoses. study design: non-randomized, non-blinded, single-center intervention study. study population: patients, 18-80 years old, undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be enrolled. a total number of 15 patients will be included in the study. intervention: gastric or esophageal resection will be executed according to the common procedures used in the umc utrecht. after construction of the esophageal anastomosis, all enrolled participants will receive a tachosil® patch, which will be applied on the esophageal anastomosis intra-operatively. hence, tachosil® is used as an add-on therapy. tachosil® will be degraded enzymatically in a period of approximately 24 weeks after application. main study parameters/endpoints: the primary endpoint is feasibility, which is assessed by evaluation of adherence of the patch. a time-action analysis of the application of the tachosil patch will be performed. nature and extent of the burden associated with participation: the burden for the patient is minimal. the total surgical procedure will be prolonged with 10-15 minutes. postoperative care and outpatient visits do not differ from regular protocol. tachosil® is approved and registered for supportive treatment in surgery for improvement of haemostasis and to promote tissue sealing by the european commission.


Eligibility criteria:
inclusion criteria: * patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis * male and female gender * ages 18-80 * signed informed consent * for females of childbearing potential: * patient uses a reliable contraceptive method: contraceptive pill, intrauterine device, subdermal implantation, or transdermal patch * patient has a negative serum or urine pregnancy test. exclusion criteria: * emergency resections of esophagus of stomach * unsigned informed consent * history of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen. * patients having difficulty understanding dutch and english * mentally incapable patients * pregnancy or breast feeding

Keywords: esophagus stomach resection esophageal disease requiring surgery gastric disease requiring surgery
effect of the use of protective masks on the ability to perform daily activities in patients with heart failure or obstructive pulmonary disease

Conditions: Heart Failure; COPD

Summary: scientific rationale: in late 2019 and early 2020, researchers at the wuhan institute of virology identified a potential new etiologic agent, called new coronavirus 2019 (ncov-2019). subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. the main tool was the requirement for all citizens to wear masks for airway protection. this measure has thus become in daily use for the majority of the population. therefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (adls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects. oxygen consumption and dyspnea during simple activities of daily living (adls) have already been studied in patients with heart failure (hf) and chronic obstructive pulmonary disease (copd), and there is evidence that these subjects compared with healthy subjects perform adls at a higher percentage of their peak vo2 with more dyspnea. however, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (ffp2) mask, to date considered the most suitable to preserve the most fragile subjects from infection. in this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform adls by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with hf or copd compared with healthy subjects.


Eligibility criteria:
inclusion criteria: healthy subjects: * age: 18-80 years * not taking cardiovascular medications * no history of cardiovascular disease * normal physical examination * normal ecg inclusion criteria for subjects with hf: * age: 18-80 years * new york heart association class (nyha) ii to iii in stable clinical condition * left ventricular ejection fraction (lvef) \<40% * ability to perform a maximal cpet patients with copd: * age: 18-80 years * diagnosis of copd stage gold ii-iii in stable clinical condition * absent concomitant heart disease * ability to perform a maximal cpet exclusion criteria: * healthy subjects: * presence of concomitant diseases patients: * oxygen therapy * inability or contraindication to perform a maximal cpet